The Recall Desk

Hazard

Quality Issue recalls

13 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
13
Critical
0
Severe
2
Most recent
2026-07-29

Of the 13 quality issue recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (15%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality issue recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–13 of 13

  • SevereFDA (Devices)·Z-2749-2026·2026-07-29

    Medline Orthopedic Surgery Kits Recalled Over Bupivacaine Quality Issue

    Medline Industries, LP is recalling 2301 convenience kits used in orthopedic joint procedures because they contain B. Braun kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which the manufacturer Huons Co, Ltd. voluntarily recalled due to quality issues.

    Product
    MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J;
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2765-2026·2026-07-29

    MEDLINE Medical Procedure Kits Containing Bupivacaine Recalled Due to Drug Ineffectiveness

    Medline Industries is recalling 318 medical procedure kits that contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection due to quality issues that could result in drug ineffectiveness.

    Product
    MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS9845
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2540-2026·2026-07-08

    Medline Suturing Set with Lidocaine Ampules Recalled

    Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2539-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2544-2026·2026-07-08

    Medline Lumbar Puncture Kit recalled for Lidocaine quality issues

    Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.

    Product
    Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3001-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2633-2024·2024-09-04

    Medline procedure packs recalled due to syringe quality issues

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2625-2024·2024-09-04

    Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.

    Product
    See RES Description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2570-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Defective Plastic Syringes

    Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2019·2019-09-11

    Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

    Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

    Product
    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0002-2019·2018-10-10

    BioLyte Recalls NeoRelief Topical Gel Due to Ingredient Contamination

    BioLyte Laboratories is recalling NeoRelief topical gel because it contains active ingredients that were previously recalled for water contamination.

    Product
    NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS — NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1093-2018·2018-03-28

    Centurion Medical Recalls IV Start Kits Due to Quality Concerns

    Centurion Medical Products Corporation is recalling IV Start Kits nationwide. The recall addresses a quality issue with the convenience kits used for IV placement.

    Product
    IV START KIT
    Category
    Medical Device
    Distribution
    0 states